GlySens ICGM

Last updated
GlySens Incorporated
Company type Private
Industry Health Care and Social Assistance
Founded1998;26 years ago (1998)
FounderJoseph Y. Lucisano & David A. Gough
Headquarters M H H private, U.S.
ProductsICGM System
Revenue$2.5 - 5 million
OwnerPrivately Owned
Number of employees
49
Website www.glysens.com

GlySens, a biomedical technology company, is a privately owned corporation developing a long term internal continuous glucose monitor in order to effectively manage and observe glucose levels in real time. The GlySens ICGM system is the world's first surgically implanted continuous glucose monitoring system to demonstrate an 18-month performance in a preclinical setting. GlySens Incorporated was founded in 1998 by David A. Gough and Joseph Lucisano, a bioengineering graduate at the University of California, San Diego. The implanted continuous glucose monitoring system uses an internal sensor equipped with electrochemical detectors to measure glucose readings via a chemical reaction between enzymes and oxygen.

Contents

Technology

The technology that goes into the ICGM system consists of two parts. Primarily is the internal sensor which utilizes chemical reactions to determine blood glucose levels. Additionally, is an external receiver used to display glucose readings and patterns in real-time, hoping to help reduce the level of care needed in diabetics.

Internal sensor

An internal glucose sensor, measuring at 38 mm across and 16 mm thick. The implant consists of an integrated glucose sensor with signal conditioning circuits, a wireless communications circuit, and a 1-year lifetime battery, all housed in a hermetically sealed (airtight) titanium housing. [1] The sensor is surgically implanted under the skin, at the waist or upper arm, and continuously monitors the glucose levels in the subcutaneous (under the skin) tissue. [2] Data is then relayed to the receiver via wireless telemetry, the automatic measurement and transmission of data by wire, radio, or other means from remote sources. The ICGM system claims to be as accurate as any other CGM device, however unlike similar products, the GlySens ICGM sensor works by detecting oxygen, allowing the system to be more stable in the interstitial fluid environment, the fluid surrounding tissue cells, than traditional CGMs. It has an outer membrane with electrochemical detectors primed with enzymes to interact with the oxygen. The extent of the enzyme reaction and the concentration of glucose can be calculated by measuring the amount of remaining oxygen from the enzyme reaction. It is ensured the sensors are working properly through multiple built-in checks. The sensor may also have applications for glucose monitoring in type 2 diabetes including caloric and activity management, and prevention of type 2 diabetes in susceptible individuals. [3]

External receiver

The monitor provides a digital readout and graphical display of the glucose levels, alerting the user to hypoglycemic and hyperglycemic glucose levels, trending patterns and a series of directional buttons to access settings, history and calibration. Calibrating the receiver and sensor is necessary in order to ensure accurate readings and is as simple as taking a transdermal blood sample and entering it into the receiver. Lucisano, GlySens Chief Technology Officer, announced that in a future iteration the receiver should be converted to a software application that can run on a cell phone. [4]

Competition

The two primary competitors of GlySens include: DexCom and Medtronic. These CGM's utilize thin wire sensors that must be inserted just under the surface of the skin and replaced at least once a week.[ citation needed ]

Studies

Science Translational Medicine reported success on long-term glucose monitoring with the sensor-telemetry system implanted in the tissues of pigs. Monitoring was carried out while the pigs were initially non-diabetic and continued for 6 months after the pigs had been made diabetic by administration of a laboratory drug. [5] The long-term animal results reported by David Gough provide a foundation for human trials, which began in January 2015 and are expected to conclude in early 2016. The first round of human trials includes a group of 20 individuals, both male and female, from the age of 21 to 65 years old. Each subject was implanted with the GlySens ICGM monitor under the skin of the upper arm and monitored over the course of 18 months. [6] The GlySens ICGM system is currently undergoing clinical evaluation, the initial human implant trials have been completed, and preparations for additional human trials are underway.

Market

In 2014 worldwide, an estimated 382 million people had diabetes, and this number is expected to double by the year 2030. In the United States alone, nearly 29 million people have been diagnosed with diabetes, and an additional 79 million people are classified as pre-diabetic. The World Health Organization projects that diabetes will be the 7th leading cause of death in 2030. [7] The worldwide annual expenditure on home and self blood glucose monitoring products has been estimated at $7 to $10 billion, with half of the sales occurring in the U.S. The total economic impact of diabetes in the U.S. is estimated at $245 billion each year. [8]

Related Research Articles

<span class="mw-page-title-main">Hypoglycemia</span> Health condition

Hypoglycemia, also called low blood sugar, is a fall in blood sugar to levels below normal, typically below 70 mg/dL (3.9 mmol/L). Whipple's triad is used to properly identify hypoglycemic episodes. It is defined as blood glucose below 70 mg/dL (3.9 mmol/L), symptoms associated with hypoglycemia, and resolution of symptoms when blood sugar returns to normal. Hypoglycemia may result in headache, tiredness, clumsiness, trouble talking, confusion, fast heart rate, sweating, shakiness, nervousness, hunger, loss of consciousness, seizures, or death. Symptoms typically come on quickly.

<span class="mw-page-title-main">Insulin pump</span> Medical device to administer insulin

An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin therapy. The device configuration may vary depending on design. A traditional pump includes:

The following is a glossary of diabetes which explains terms connected with diabetes.

<span class="mw-page-title-main">Blood glucose monitoring</span> Use of a glucose monitor for testing the concentration of glucose in the blood

Blood glucose monitoring is the use of a glucose meter for testing the concentration of glucose in the blood (glycemia). Particularly important in diabetes management, a blood glucose test is typically performed by piercing the skin to draw blood, then applying the blood to a chemically active disposable 'test-strip'. The other main option is continuous glucose monitoring (CGM). Different manufacturers use different technology, but most systems measure an electrical characteristic and use this to determine the glucose level in the blood. Skin-prick methods measure capillary blood glucose, whereas CGM correlates interstitial fluid glucose level to blood glucose level. Measurements may occur after fasting or at random nonfasting intervals, each of which informs diagnosis or monitoring in different ways.

<span class="mw-page-title-main">Blood sugar level</span> Concentration of glucose present in the blood (Glycaemia)

The blood sugar level, blood sugar concentration, blood glucose level, or glycemia is the measure of glucose concentrated in the blood. The body tightly regulates blood glucose levels as a part of metabolic homeostasis.

<span class="mw-page-title-main">Glucose oxidase</span> Class of enzymes

The glucose oxidase enzyme also known as notatin is an oxidoreductase that catalyses the oxidation of glucose to hydrogen peroxide and D-glucono-δ-lactone. This enzyme is produced by certain species of fungi and insects and displays antibacterial activity when oxygen and glucose are present.

Glycated hemoglobin is a form of hemoglobin (Hb) that is chemically linked to a sugar. Most monosaccharides, including glucose, galactose and fructose, spontaneously bond with hemoglobin when present in the bloodstream. However, glucose is only 21% as likely to do so as galactose and 13% as likely to do so as fructose, which may explain why glucose is used as the primary metabolic fuel in humans.

<span class="mw-page-title-main">Glucose meter</span> Medical device for determining the concentration of glucose in the blood

A glucose meter, also referred to as a "glucometer", is a medical device for determining the approximate concentration of glucose in the blood. It can also be a strip of glucose paper dipped into a substance and measured to the glucose chart. It is a key element of glucose testing, including home blood glucose monitoring (HBGM) performed by people with diabetes mellitus or hypoglycemia. A small drop of blood, obtained from slightly piercing a fingertip with a lancet, is placed on a disposable test strip that the meter reads and uses to calculate the blood glucose level. The meter then displays the level in units of mg/dL or mmol/L.

The term diabetes includes several different metabolic disorders that all, if left untreated, result in abnormally high concentrations of a sugar called glucose in the blood. Diabetes mellitus type 1 results when the pancreas no longer produces significant amounts of the hormone insulin, usually owing to the autoimmune destruction of the insulin-producing beta cells of the pancreas. Diabetes mellitus type 2, in contrast, is now thought to result from autoimmune attacks on the pancreas and/or insulin resistance. The pancreas of a person with type 2 diabetes may be producing normal or even abnormally large amounts of insulin. Other forms of diabetes mellitus, such as the various forms of maturity-onset diabetes of the young, may represent some combination of insufficient insulin production and insulin resistance. Some degree of insulin resistance may also be present in a person with type 1 diabetes.

Many types of glucose tests exist and they can be used to estimate blood sugar levels at a given time or, over a longer period of time, to obtain average levels or to see how fast body is able to normalize changed glucose levels. Eating food for example leads to elevated blood sugar levels. In healthy people, these levels quickly return to normal via increased cellular glucose uptake which is primarily mediated by increase in blood insulin levels.

The polyol pathway is a two-step process that converts glucose to fructose. In this pathway glucose is reduced to sorbitol, which is subsequently oxidized to fructose. It is also called the sorbitol-aldose reductase pathway.

Automated insulin delivery systems are automated systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems can only deliver a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.

<span class="mw-page-title-main">Minimed Paradigm</span> Insulin pumps

MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.

DexCom, Inc. is a company that develops, manufactures, produces, and distributes continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with headquarters in San Diego, California, and has manufacturing facilities in Mesa, Arizona and Batu Kawan, Malaysia.

Fluorescent glucose biosensors are devices that measure the concentration of glucose in diabetic patients by means of sensitive protein that relays the concentration by means of fluorescence, an alternative to amperometric sension of glucose. Due to the prevalence of diabetes, it is the prime drive in the construction of fluorescent biosensors. A recent development has been approved by the FDA allowing a new continuous glucose monitoring system called EverSense, which is a 90-day glucose monitor using fluorescent biosensors.

<span class="mw-page-title-main">Adam Heller</span> Israeli-American engineer (born 1933)

Adam Heller is an Israeli American scientist and engineer. He is Chief Science Officer of SynAgile Corp. of Wilson, Wyoming, consults to Abbott Diabetes Care of Alameda, California, and is Ernest Cockrell Sr. Chair Emeritus of Engineering at The University of Texas at Austin. His 1973 paper with James J. Auborn established the feasibility of high energy density, high-voltage, non-rechargeable lithium batteries. Their 3.6-volt lithium thionyl chloride and 3.7-volt lithium sulfuryl chloride batteries remain in use in applications requiring very high energy density and a shelf life of 20 years or more.

Ambulatory glucose profile (AGP) is a single-page, standardized report for interpreting a patient's daily glucose and insulin patterns. AGP provides both graphic and quantitative characterizations of daily glucose patterns. First developed by Drs. Roger Mazze and David Rodbard, with colleagues at the Albert Einstein College of Medicine in 1987, AGP was initially used for the representation of episodic self-monitored blood glucose (SMBG). The first version included a glucose median and inter-quartile ranges graphed as a 24-hour day. Dr. Mazze brought the original AGP to the International Diabetes Center (IDC) in the late 1980s. Since then, IDC has built the AGP into the internationally recognized standard for glucose pattern reporting.

<span class="mw-page-title-main">Continuous glucose monitor</span> Blood glucose monitoring device

A continuous glucose monitor (CGM) is a device used for monitoring blood glucose on a continual basis instead of monitoring glucose levels periodically by drawing a drop of blood from a finger. This is known as continuous glucose monitoring. CGMs are used by people who treat their diabetes with insulin, for example people with type 1 diabetes, type 2 diabetes, or other types of diabetes, such as gestational diabetes.

Bioinstrumentation or Biomedical Instrumentation is an application of biomedical engineering which focuses on development of devices and mechanics used to measure, evaluate, and treat biological systems. The goal of biomedical instrumentation focuses on the use of multiple sensors to monitor physiological characteristics of a human or animal for diagnostic and disease treatment purposes. Such instrumentation originated as a necessity to constantly monitor vital signs of Astronauts during NASA's Mercury, Gemini, and Apollo missions.

Nemaura Medical Inc. is a UK based Medical Technology company developing a wireless non-invasive blood glucose monitoring system called SugarBeAT.

References

  1. Fitzpatrick, Dennis (2015-01-01). Fitzpatrick, Dennis (ed.). Chapter 4 - Glucose Biosensors. Oxford: Academic Press. pp. 37–51. ISBN   978-0-12-416556-4.
  2. "Glysens Incorporated - UC San Diego Office of Innovation and Commercialization". UC San Diego Office of Innovation and Commercialization. Retrieved 2015-10-21.
  3. "Clinical Evaluation of a Long Term Implanted Glucose Sensor - Glysens, Inc. - SBIR Source". SBIRSource.com. Retrieved 2015-11-04.
  4. "No more needles: Startup tests implant that can measure blood sugar for up to a year - MedCity News". MedCity News. 2 April 2014. Retrieved 2015-10-21.
  5. Gough, David A.; Kumosa, Lucas S.; Routh, Timothy L.; Lin, Joe T.; Lucisano, Joseph Y. (2010-07-28). "Function of an Implanted Tissue Glucose Sensor for More than 1 Year in Animals". Science Translational Medicine. 2 (42): 42ra53. doi:10.1126/scitranslmed.3001148. ISSN   1946-6234. PMC   4528300 . PMID   20668297.
  6. "Function of Implanted Glucose Sensor 2 - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2015-10-21.
  7. "WHO | Diabetes". www.who.int. Archived from the original on 2013-08-26. Retrieved 2015-11-04.
  8. "Glysens Incorporated - UC San Diego Office of Innovation and Commercialization". UC San Diego Office of Innovation and Commercialization. Retrieved 2015-10-29.